Evaluation of the Efficacy and Tolerability of the Mediterranean Diet Pattern in the Exclusion Diet for Patients With Crohn's Disease.

Crohn Disease Clinical Trial

Official title:

Adaptation of the Mediterranean Diet Pattern to the Exclusion Diet for Crohn's Disease: Assessment of Efficacy and Tolerability in Pediatric and Adult Patients. Non-profit, Multicenter, Randomized, Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324513
• Other study ID #: Med-CDED
• Status: Recruiting
• Phase: N/A
• Start date: July 27, 2023
• Est. completion date: October 27, 2025

Study information

• Verified date: March 2024
• Source: Meyer Children's Hospital IRCCS
• Contact: Paolo Lionetti, MD
• Phone: 3398416059
• Email: paolo.lionetti[@]meyer.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed study aims to assess the efficacy and tolerability of adapting the CDED to the Mediterranean diet pattern, without compromising its key principles, namely the exclusion of ultra-processed foods with potential pro-inflammatory effects on the intestines. The decision to modify the CDED according to the characteristics of the Mediterranean diet pattern and to evaluate the potential of this modified version of the exclusion diet for Crohn's disease in terms of efficacy and tolerability are the main objectives of this study.

These objectives are driven not only by scientific evidence regarding the anti-inflammatory potential and protective role against chronic-degenerative diseases demonstrated by the Mediterranean diet but also to allow for greater adherence to Italian dietary traditions and improve compliance with the dietary regimen.

Furthermore, to date, there are no comprehensive multi-omic investigations integrating dietary data with microbiome, metabolome, and transcriptome profiles that can demonstrate the effect of the CDED at "omic" levels. A very recent study on pediatric patients shows interesting results regarding differential profiles of fecal metabolites after administration of CDE or NEE in different weeks of therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 27, 2025
• Est. primary completion date: July 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with a stable diagnosis of Crohn's disease according to the criteria of the ECCO/ESPGHAN guidelines.

• Patients with a new diagnosis of the disease or with a disease diagnosed no more than three years ago, receiving stable pharmacological therapy for at least 2 months with immunomodulators (thiopurines, methotrexate, azathioprine) or biologic drugs who have experienced a disease relapse and require reinduction of remission.

• Mild to moderate disease activity assessed by the wPCDAI score between 12.5-57.5 in the pediatric population and a Harvey-Bradshaw Index ranging from 5 to 16 for the adult population.

• Biochemical evidence of active intestinal inflammation at enrollment, assessed by inflammatory markers such as C-reactive protein (CRP) levels = 0.5 mg/dl or fecal calprotectin = 150 mg/g.

• Ability to provide biological samples (stool and blood samples).

Exclusion Criteria:

• Monogenic disease;

• Disease with fibrostenotic or penetrating phenotype;

• Complex perianal fistulizing disease not completely in remission;

• Patients with ileostomy or who have undergone intestinal resection or colectomy;

• Patients currently undergoing other nutritional therapy (e.g., exclusive enteral nutrition) or who have undergone it in the last month;

• Patients not on stable therapy with immunomodulators or biologic drugs or who started therapy with thiopurines less than 4 weeks before enrollment, or methotrexate less than 8 weeks before enrollment;

• Patients with recent use of systemic steroids in the four weeks before enrollment or recent initiation or dose adjustment phase of therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) or biologic drugs;

• Pregnancy;

• Vegan or vegetarian patients;

• Celiac disease.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• Mediterranean Crohn's Disease Exclusion Diet (Med-CDED)
The Mediterranean Crohn's Disease Exclusion Diet (Med-CDED) is the exclusion diet (CDED) adapted to the Mediterranean diet pattern. The Med-CDED consists of 2 phases in dietary therapy and a maintenance phase: the first phase lasting 8 weeks, the second phase lasting 16 weeks, and the maintenance phase, which for the purposes of the study will last 28 weeks.
• Crohn's disease exclusion diet (CDED)
The original Crohn's disease exclusion diet, used as a comparator, is widely employed among first-line treatments in clinical practice for inducing remission in pediatric patients with Crohn's disease.

Locations

Country	Name	City	State
Italy	Meyer Children's Hospital IRCCS	Firenze
Italy	Ospedali Riuniti Villa Sofia-Cervello	Palermo
Italy	Università La Sapienza di Roma	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response to the first phase of diet	reduction of 12.5 points in the wPCDAI score.	8 weeks
Primary	Clinical remission rate	wPCDAI score must be <12.5 points after the first phase of diet	8 weeks
Primary	Adherence rate to the Med-CDED diet and comparison to the original CDED both in pediatric and adult cohort	Adherence rate will be assessed by adherence questionnaire score or by considering the number of patients who refuse the diet	Anytime during the study
Primary	Clinical remission rate in adult patients at the end of phase I of diet	Clinical remission will be assessed by HBI < 5 points	8 weeks
Secondary	Transmural response of the thickness of the intestinal loops both in pediatric and adult cohort	The thickness of intestinal loops will be assess by using ultrasound	0, 8, 24, 38 and 52 weeks
Secondary	Assessment of the reduction or normalization of inflammation markers both in pediatric and adult cohort	ESR, CPR and fecal calprotectin will be measured at the end of phase I of the diet	8 weeks
Secondary	Assessment of clinical remission rate at the end of Phase II of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort	Assessment of clinical remission rate at Phase II of both diet protocols	24 weeks
Secondary	Assessment of clinical remission rate at the end of Phase III of the Med-CDED diet and comparision with the original CDED both in pediatric and adult cohort	Assessment of clinical remission rate at Phase III of both diet protocols	52 weeks
Secondary	Endoscopic response rate obtained at 6 months both in pediatric and adult cohort	The assessment will be performed in a subgroup of partecipants that will recive endoscopy at baseline and after 6 months	0 and 26 weeks
Secondary	Assessment of the modification of the intestinal microbiota composition (trough alpha and beta diversity) at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort	Bioinformatic analysis of the composition of the intestinal microbiota will be performed after extraction of bacterial genomic DNA from the collected faecal samples and NGS sequencing with the Illumina MiSeq platform. These analyses will allow taxonomic identification of theintestinal microbial communities in each patient. Indices of microbial richness and biodiversity (Chao index, Shannon and Simpson index) will be calculated, and principal coordinate (PCoA) and multidimensional (NMDS) analyses will be performed to assess variability in microbial composition between the various phases of the dietary intervention.	52 weeks
Secondary	Assessment of the metabolome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort	faecal metabolome will be carried out by gas chromatography and mass spectrometry analysis. The identification of differentially abundant metabolites will be carried out by comparing profiles at various stages of the dietary intervention.	52 weeks
Secondary	Assessment of the trascriptome profiles at the end of the various phases of the Med-CDED and comparison with the original CDED both in pediatric and adult cohort	Transcriptome investigation of blood samples, gene expression profiles of the individual's RNA, will be identified by NGS sequencing techniques. Transcriptomic analysis will be performed in R using the DESeq2 package	52 weeks
Secondary	Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment both in pediatric and adult cohortreceived	Ability to maintain a healthy and balanced diet and patient satisfaction with the treatment recived assessed with nutritional questionnair	Anytime during the study